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Clinical Trial Details

Trial ID: L4667
Source ID: NCT01398423
Associated Drug: Active Control
Title: INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hypertension|Diabetes Mellitus, Type 2
Interventions: DRUG: Active Control|DRUG: INV-144
Outcome Measures: Primary: Safety, Safety will be monitored throughout the study by evaluation of adverse events (AEs), physical examinations (PEs), clinical laboratory results, vital signs, and electrocardiograms (ECGs)., 12 weeks | Secondary: Efficacy, Efficacy will be evaluated by measurement of UACR, systolic and diastolic blood pressure, and the HOMA-IR ratio., 12 weeks
Sponsor/Collaborators: Sponsor: InVasc Therapeutics, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 88
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-07
Results First Posted:
Last Update Posted: 2012-08-07
Locations: Garden Grove, California, 92844, United States|La Mesa, California, 91942, United States|Northridge, California, 91324, United States|Riverside, California, 92505, United States|Tustin, California, 92780, United States|Kissimmee, Florida, 34741, United States|Miami, Florida, 33015, United States|Macon, Georgia, 31217, United States|Tucker, Georgia, 30084, United States|Reisterstown, Maryland, 21136, United States|Brooklyn Center, Minnesota, 55430, United States|Cary, North Carolina, 27511, United States|Greenville, North Carolina, 27834, United States|New Bern, North Carolina, 28562, United States|Raleigh, North Carolina, 27610, United States|Aiken, South Carolina, 29801, United States|San Antonio, Texas, 78215, United States|San Antonio, Texas, 78228, United States|Norfolk, Virginia, 23507, United States
URL: https://clinicaltrials.gov/show/NCT01398423